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NCT06639256
An Open-label, Multiple-center, Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
Phase 1/Phase 2 trial testing Test Product HY07121 in Safety in 258 participants. Currently enrolling.
1 May 2026
Quick facts
| Lead sponsor | Sichuan Huiyu Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 258 |
| Start date | 24 October 2024 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 October 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Test Product HY07121 — full drug profile →
Conditions studied
- Safety — all drugs for Safety →
- Tolerability — all drugs for Tolerability →
- Efficacy — all drugs for Efficacy →
Sponsor
Sichuan Huiyu Pharmaceutical Co., Ltd — full company profile →
Who can join
Adults 18 to 80, any sex, with Safety or Tolerability. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT)
Time frame: 21 days during the first 3-week cycle
Dose-Limiting Toxicity (DLT) will be defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) criteria for Cytokine Release Syndrome (CRS). -
Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading -
Dose Escalation (Part One): Percentage of participants experiencing Adverse Event (AE) related dose interruptions, dose delays, and dose intensity
Time frame: Up to 2 years
Occurrence of Adverse Event (AE) related dose interruptions, dose delays and dose intensity (duration of HY07121 exposure) -
Dose Expansion (Part Two): Objective Response Rate (ORR)
Time frame: Up to 2 years
Proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR)
Sponsor's own description
This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06639256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Sichuan Huiyu Pharmaceutical Co., Ltd trials
Trials by the same sponsor.
- NCT07083323 — A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06977490 — Human Bioequivalence Study of Amphotericin B Liposome for Injection · NA · completed
- NCT06895993 — Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants · Phase 1 · completed
- NCT06765590 — Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer · NA · recruiting
- NCT06756490 — A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06639256 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sichuan Huiyu Pharmaceutical Co., Ltd
- Last refreshed: 26 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06639256.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing